Journal article

Evaluation of Combination Nivolumab and Ipilimumab Immunotherapy in Patients With Advanced Biliary Tract Cancers Subgroup Analysis of a Phase 2 Nonrandomized Clinical Trial

Oliver Klein, Damien Kee, Adnan Nagrial, Ben Markman, Craig Underhill, Michael Michael, Louise Jackett, Caroline Lum, Andreas Behren, Jodie Palmer, Niall C Tebbutt, Matteo S Carlino, Jonathan Cebon



Importance: Biliary tract cancers represent a rare group of malignant conditions with very limited treatment options. Patients with advanced disease have a poor outcome with current therapies. Objective: To evaluate the efficacy and safety of combination immunotherapy with nivolumab and ipilimumab in patients with advanced biliary tract cancers. Design, Setting, and Participants: The CA209-538 prospective multicenter phase 2 nonrandomized clinical trial included patients with advanced rare cancers including patients with biliary tract cancers. This subgroup analysis evaluated 39 patients from CA209-538 with biliary tract cancers who were enrolled from December 2017 to December 2019. Most of ..

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Funding Acknowledgements

The study received funding and drug support from Bristol-Myers Squibb; grant funding support was received for patient costs provided by the Australian Commonwealth Department, Health under the Medical Research Futures Fund (patients 21-39). Dr Behren is supported by a fellowship from the Department of Health and Human Services acting through the Victorian Cancer Agency.